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Post approval services for pharmaceutical and biotech companies range from patient registries, Phase IV, Non interventional programs, pharmacovigilance etc. Services span to the entire life cycle of the drug post marketing with a keen focus on meeting challenges and addressing FDA/EMEA safety norms. The need for more safe and reliable drugs has led to robust post approval pharmacovigilance, leading to pressure on both, pharmaceutical and biopharmaceutical world. PV services helps the management strategize and plan for post marketing FDA/MHRA/EMEA scrutinization. Post-marketing safety services include adverse event report case management (receipt, tracking, data entry, assessment, coding, and follow-up); electronic submission of individual case safety reports to regulatory authorities; literature review for reports of adverse events; aggregate reporting; and signal detection. Preparation of risk management plans, negotiation of risk management strategy with regulatory agencies, and execution of risk management strategies including Late Phase studies, Medical information submission and safety norm analysis. To meet the strict regulatory requirements, along with managing the risk-benefit profile of products, and in order to maximise product potential, whilst ensuring patient safety safety data, clinical data, analysis and reporting is done diligently and some time it involves epidemiological data as well. Post authorisation services include PV Consultancy and Project Management, Individual Case Safety Report (ICSR) Processing of Initial/Follow-up reports, MedDRA coding, Case Narratives, Pharmacovigilance Physician services, Global Expedited Case Reporting, EudraVigilance reporting using EVWEB, Safety Data Management & Global Safety Database - Oracle Argus, Signal Detection & Evaluation, Periodic Safety Update Report (PSUR) preparation and submission, Global Literature Search & Review, Local literature review, Pharmacovigilance Quality Assurance including SOP development, Pharmacovigilance Awareness Training, Safety Data Exchange Agreements (SDEAs) and reconciliation of ICSRs with partners, Risk Management Plan production, review and maintenance, Pharmacovigilance System Master File (PSMF), Company Core Safety Information (CCSI) production and maintenance, Regulatory Intelligence, Adverse Event Follow-up, Product Quality Complaints, Pre/Post-Marketing Clinical Studies, Development of Medical Information, Special Projects, Draft report preparation for PMDA (infectious diseases, researches, overseas safety measures) and SGML file generation, Draft DSUR preparation, PSURs/PBRERs and PADERs, COs and ACOs, etc. Another key requirement of the EU legislation for PV studies is the stipulation that, without exception, a Qualified Person for Pharmacovigilance (QPPV) must be appointed to oversee the pharmacovigilance services for authorised products held by the company. The regulatory updates in major CRO’s are maintained in an online system for real time access. This includes Competent Authority, Ethics Committee and Investigator safety set-up and expedited and periodic submission decisions for Clinical Trials, Post-Marketing, Medical Devices, In Vitro Diagnostics, along with scope for other areas.IT and surveillance related services for a robust PV study includes Implementation, validation, maintenance & upgrade of Argus applications, Design, development & submission of regulatory, operational, analytical & custom reports, Validated and up-to-date case processing platform in a secure environment, Signal evaluation/assessment and reporting, Meta-analysis of published safety data etc. Natural history studies, Pragmatic trials, Disease/drug registries, Quality-of-life and patient-reported outcomes, Health outcomes/health economics, Comparative effectiveness studies, Real-world data for healthcare decision making are some of the studies/ questions which need to be answered during Life cycle management studies of a drug. LCM studies include Method development, transfer and phase appropriate validation, Release and stability testing from preclinical phases through the commercial life of product, Monitoring and identification of data trends ? control charting & review, In process testing, Reference standard and critical reagent control and distribution, Active monitoring and reporting from proposal to invoice through a single point of contact, Project planning and key project milestones with dates of deliverables, Project scope definition and accuracy of the contract, Reference standard and critical reagent control and distribution, Communication of project updates, Monitoring of work scope changes and reconciliation of financials, Change in manufacturing site, addition/deletion, Optimization of manufacturing process, Change in formulation, Batch size change, Addition of new supplier for active substance, Inclusion of additional source for starting material for drug substance, Change in route of synthesis, Certification of Suitability (CEP) updates/new CEP, Change in equipment/instruments, Monograph updates i.e. Compliance to Pharmacopoeia, Analytical method changes, Changes in container closure system, Change in primary packaging material supplier and Shelf life extension/reduction. Generics account for a significant percentage of the global small-molecule drug market today, and biosimilars are poised to make strong gains in the biopharmaceutical sector. Aggressive generics/biosimilar companies develop their products parallel to the innovator company and increasingly are introducing them before patent protections on branded counterparts have expired. Consequently, pharmaceutical product life cycle management (LCM) strategies can no longer focus solely on the period from launch to patent expiry. Successful drug manufacturers now include the entire lifecycle from discovery through end of life. Contract development and manufacturing organizations (CDMOs) with expertise in both the development and commercialization of new drug products and life cycle management strategies play a key role in supporting these much more extensive and complex LCM activities.

PHARMACOVIGILANCE / PRODUCT LIFECYCLE MANAGEMENT
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Chiltern International Ltd

Covigilant LLC

Factory CRO

Greenleaf Health Inc

ICBio Clinical Research Pvt Ltd

KAI Research

Mapi Group

Nutrasource

PAREXEL International Corporation

Pharmaceutical Product Development, LLC

TFS International AB

TransPerfect

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Periodic Benefit-Risk Evaluation Reports (PBR...

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Based on our extensive pharmacovigilance operations experience, we customize database software query tools to expand your data mining capabilities.

- Directory Listing

Pharma Service: Clinical Trials

Category: Post Marketing

Sub Category: Pharmacovigilance / Product Lifecycle Management

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Pharmacovigilance & Safety Reporting

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We enable global clinical development teams to rapidly translate and share pharmacovigilance information, such as SUSARs (suspected unexpected serious adverse reactions), SAEs (serious adverse events), hospitalization reports, and discharge summaries, within a centralized collaborative workspace.

- Directory Listing

Pharma Service: Clinical Trials

Category: Post Marketing

Sub Category: Pharmacovigilance / Product Lifecycle Management

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Late Phase Partnerships

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PAREXEL's Peri/Post-Approval Services group of experts are dedicated to late phase research, offering a proven partnership model designed specifically for Late Phase.

- Directory Listing

Pharma Service: Clinical Trials

Category: Post Marketing

Sub Category: Pharmacovigilance / Product Lifecycle Management

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Postmarketing Surveillance (PMS)

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Factory has expertise in the design, conduct, analysis and reporting of PMS studies. Results from well-designed PMS studies can strengthen your marketing and sales efforts.

- Directory Listing

Pharma Service: Clinical Trials

Category: Post Marketing

Sub Category: Pharmacovigilance / Product Lifecycle Management

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Development Safety Update Reports (DSUR)

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Based on our extensive pharmacovigilance operations experience, we customize database software query tools to expand your data mining capabilities.

- Directory Listing

Pharma Service: Clinical Trials

Category: Post Marketing

Sub Category: Pharmacovigilance / Product Lifecycle Management

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Global Post-Approval Services

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Our clinical experience in product development ensures collaboration and integration from pre-approval to post-approval. We provide a custom-tailored process, fine-tuned across the globe, to meet local regulatory requirements.

- Directory Listing

Pharma Service: Clinical Trials

Category: Post Marketing

Sub Category: Pharmacovigilance / Product Lifecycle Management

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Pharmacovigilance & Risk Management

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Mapi provides a flexible, global pharmacovigilance service supporting regulatory compliance and management of patient safety issues.

- Directory Listing

Pharma Service: Clinical Trials

Category: Post Marketing

Sub Category: Pharmacovigilance / Product Lifecycle Management

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Epidemiology

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At PAREXEL® we have senior Epidemiologists, and Statisticians, who have many years experience within the pharmaceutical industry providing solutions to the questions faced by our clients.

- Directory Listing

Pharma Service: Clinical Trials

Category: Post Marketing

Sub Category: Pharmacovigilance / Product Lifecycle Management

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SAE / AE Reporting

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Our MDs are experts in the safety evaluation and handling of Serious Adverse Events that are reported during the trial follow up period.

- Directory Listing

Pharma Service: Clinical Trials

Category: Post Marketing

Sub Category: Pharmacovigilance / Product Lifecycle Management

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Product Lifecycle Management

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Greenleaf Health Inc. offers various services such as: Strategic guidance on FDA’s regulatory process; All aspects of product development; Premarket review; Postmarket safety requirements; Analysis of the market to identify potential competition.

- Directory Listing

Pharma Service: Clinical Trials

Category: Post Marketing

Sub Category: Pharmacovigilance / Product Lifecycle Management

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Pharmacovigilance

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Our global Pharmacovigilance teams have the knowledge of local regulations, standards of care and cultural customs you need to identify and assess risks during your clinical trial — keeping patient safety a top priority. And, we have locations around the world to accommodate your trials wherever

- Directory Listing

Pharma Service: Clinical Trials

Category: Post Marketing

Sub Category: Pharmacovigilance / Product Lifecycle Management

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Safety & Pharmacovigilance

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Our team of Drug Safety Associates (DSAs) provides clinical safety and pharmacovigilance support for biopharmaceuticals throughout the product life cycle.

- Directory Listing

Pharma Service: Clinical Trials

Category: Post Marketing

Sub Category: Pharmacovigilance / Product Lifecycle Management

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End-of-Trial Declarations

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The TFS Regulatory Affairs Unit offers operational and strategic consulting services and has extensive experience in managing all aspects of regulatory affairs, supporting a product from the drug development phase throughout all phases of clinical development to market authorization and product

- Directory Listing

Pharma Service: Clinical Trials

Category: Post Marketing

Sub Category: Pharmacovigilance / Product Lifecycle Management

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Pharmacovigilance Services

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Our experienced team of more than 700 pharmacovigilance professionals worldwide provide 24/7/365 availability and is fully focused on identifying and applying valuable insights based on pharmacovigilance needs.

- Directory Listing

Pharma Service: Clinical Trials

Category: Post Marketing

Sub Category: Pharmacovigilance / Product Lifecycle Management

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Drug Safety Services

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PAREXEL understands that patient safety is at the heart of every company’s focus. This is why we are committed to delivering quality, integrated drug safety services across the full spectrum of the post-approval life cycle.

- Directory Listing

Pharma Service: Clinical Trials

Category: Post Marketing

Sub Category: Pharmacovigilance / Product Lifecycle Management

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Risk Management & REMS Strategies

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Our risk management team works in a matrix approach with departments across PPD. Experts in epidemiology, registries and observational studies, regulatory affairs, pharmacovigilance and call center operations provide support to REMS programs.

- Directory Listing

Pharma Service: Clinical Trials

Category: Post Marketing

Sub Category: Pharmacovigilance / Product Lifecycle Management

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Medical Affairs & Pharmacovigilance

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As part of our mission of ensuring sound scientific evidence in support of safe and effective products, our team places emphasis on product safety. We offer our clients a flexible suite of pharmacovigilance services during product development.

- Directory Listing

Pharma Service: Clinical Trials

Category: Post Marketing

Sub Category: Pharmacovigilance / Product Lifecycle Management

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Safety Surveillance & Predictive Signal Detec...

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Chiltern’s industry-leading team of data management professionals and statisticians is one of the largest in the industry. With real-world experience in adaptive trial designs and the latest data analytics platforms and technologies, we make certain you can not only access, but also examine

- Directory Listing

Pharma Service: Clinical Trials

Category: Post Marketing

Sub Category: Pharmacovigilance / Product Lifecycle Management

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Safety Surveillance / Observational Programs

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Over the last three decades, our medical device study team has successfully managed hundreds of studies for all classes of medical products.

- Directory Listing

Pharma Service: Clinical Trials

Category: Post Marketing

Sub Category: Pharmacovigilance / Product Lifecycle Management

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Pharmacovigilance & Drug Safety

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- Service Details

The Drug Safety Unit has extensive experience in managing all aspects of drug safety/pharmacovigilance services, from the drug development phase through to market authorization surveillance and the set-up of a pharmacovigilance system.

- Directory Listing

Pharma Service: Clinical Trials

Category: Post Marketing

Sub Category: Pharmacovigilance / Product Lifecycle Management

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Pharmaceutical Risk Management

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PAREXEL's Pharmacovigilance services includes a wealth of experts in the field of Risk Management planning and strategy, many with FDA and MHRA backgrounds.

- Directory Listing

Pharma Service: Clinical Trials

Category: Post Marketing

Sub Category: Pharmacovigilance / Product Lifecycle Management

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Safety Reporting & Pharmacovigilance Services

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- Service Details

We, at ICBio, offer complete Pharmacovigilance Services, which include data collection, processing, medical review, safety writing, report writing, reporting, signal detection and analysis.

- Directory Listing

Pharma Service: Clinical Trials

Category: Post Marketing

Sub Category: Pharmacovigilance / Product Lifecycle Management

Post approval services for pharmaceutical and biotech companies range from patient registries, Phase IV, Non interventional programs, pharmacovigilance etc. Services span to the entire life cycle of the drug post marketing with a keen focus on meeting challenges and addressing FDA/EMEA safety norms. The need for more safe and reliable drugs has led to robust post approval pharmacovigilance, leading to pressure on both, pharmaceutical and biopharmaceutical world. PV services helps the management strategize and plan for post marketing FDA/MHRA/EMEA scrutinization. Post-marketing safety services include adverse event report case management (receipt, tracking, data entry, assessment, coding, and follow-up); electronic submission of individual case safety reports to regulatory authorities; literature review for reports of adverse events; aggregate reporting; and signal detection. Preparation of risk management plans, negotiation of risk management strategy with regulatory agencies, and execution of risk management strategies including Late Phase studies, Medical information submission and safety norm analysis. To meet the strict regulatory requirements, along with managing the risk-benefit profile of products, and in order to maximise product potential, whilst ensuring patient safety safety data, clinical data, analysis and reporting is done diligently and some time it involves epidemiological data as well. Post authorisation services include PV Consultancy and Project Management, Individual Case Safety Report (ICSR) Processing of Initial/Follow-up reports, MedDRA coding, Case Narratives, Pharmacovigilance Physician services, Global Expedited Case Reporting, EudraVigilance reporting using EVWEB, Safety Data Management & Global Safety Database - Oracle Argus, Signal Detection & Evaluation, Periodic Safety Update Report (PSUR) preparation and submission, Global Literature Search & Review, Local literature review, Pharmacovigilance Quality Assurance including SOP development, Pharmacovigilance Awareness Training, Safety Data Exchange Agreements (SDEAs) and reconciliation of ICSRs with partners, Risk Management Plan production, review and maintenance, Pharmacovigilance System Master File (PSMF), Company Core Safety Information (CCSI) production and maintenance, Regulatory Intelligence, Adverse Event Follow-up, Product Quality Complaints, Pre/Post-Marketing Clinical Studies, Development of Medical Information, Special Projects, Draft report preparation for PMDA (infectious diseases, researches, overseas safety measures) and SGML file generation, Draft DSUR preparation, PSURs/PBRERs and PADERs, COs and ACOs, etc. Another key requirement of the EU legislation for PV studies is the stipulation that, without exception, a Qualified Person for Pharmacovigilance (QPPV) must be appointed to oversee the pharmacovigilance services for authorised products held by the company. The regulatory updates in major CRO’s are maintained in an online system for real time access. This includes Competent Authority, Ethics Committee and Investigator safety set-up and expedited and periodic submission decisions for Clinical Trials, Post-Marketing, Medical Devices, In Vitro Diagnostics, along with scope for other areas.IT and surveillance related services for a robust PV study includes Implementation, validation, maintenance & upgrade of Argus applications, Design, development & submission of regulatory, operational, analytical & custom reports, Validated and up-to-date case processing platform in a secure environment, Signal evaluation/assessment and reporting, Meta-analysis of published safety data etc. Natural history studies, Pragmatic trials, Disease/drug registries, Quality-of-life and patient-reported outcomes, Health outcomes/health economics, Comparative effectiveness studies, Real-world data for healthcare decision making are some of the studies/ questions which need to be answered during Life cycle management studies of a drug. LCM studies include Method development, transfer and phase appropriate validation, Release and stability testing from preclinical phases through the commercial life of product, Monitoring and identification of data trends ? control charting & review, In process testing, Reference standard and critical reagent control and distribution, Active monitoring and reporting from proposal to invoice through a single point of contact, Project planning and key project milestones with dates of deliverables, Project scope definition and accuracy of the contract, Reference standard and critical reagent control and distribution, Communication of project updates, Monitoring of work scope changes and reconciliation of financials, Change in manufacturing site, addition/deletion, Optimization of manufacturing process, Change in formulation, Batch size change, Addition of new supplier for active substance, Inclusion of additional source for starting material for drug substance, Change in route of synthesis, Certification of Suitability (CEP) updates/new CEP, Change in equipment/instruments, Monograph updates i.e. Compliance to Pharmacopoeia, Analytical method changes, Changes in container closure system, Change in primary packaging material supplier and Shelf life extension/reduction. Generics account for a significant percentage of the global small-molecule drug market today, and biosimilars are poised to make strong gains in the biopharmaceutical sector. Aggressive generics/biosimilar companies develop their products parallel to the innovator company and increasingly are introducing them before patent protections on branded counterparts have expired. Consequently, pharmaceutical product life cycle management (LCM) strategies can no longer focus solely on the period from launch to patent expiry. Successful drug manufacturers now include the entire lifecycle from discovery through end of life. Contract development and manufacturing organizations (CDMOs) with expertise in both the development and commercialization of new drug products and life cycle management strategies play a key role in supporting these much more extensive and complex LCM activities.

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